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临床试验/NCT03028402
NCT03028402已完成不适用

Adjacent Segment Mechanics in Cervical Arthrodesis Patients

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
106
试验地点
1
主要终点
Iatrogenic factors

研究概览

简要总结

This study aims to determine to what extent patient-specific factors, iatrogenic factors, and biomechanical factors influence cervical spine mechanics after single-level and two-level arthrodesis.

详细描述

The etiology of adjacent segment pathology following cervical fusion remains highly controversial. Adjacent segment disease is believed to result from one or more of the following distinct causes:

  1. the natural history of the adjacent disc;
  2. disruption of the adjacent segment anatomy due to the initial surgery; and
  3. biomechanical stress on the adjacent level following the fusion.

The long-term goal of our research is to reduce or prevent symptomatic adjacent segment degeneration in the spine. The overall hypothesis of this study is that adjacent segment kinematics (i.e. translations, rotations, helical axis of motion) and arthrokinematics (i.e. disc deformation and facet joint surface interactions) after ACDF are determined primarily by patient-specific anatomy and iatrogenic factors, and not by increased biomechanical stress due to the fusion.

A prospective longitudinal study is proposed to determine to what extent patient-specific factors (Specific Aim 1), iatrogenic factors (Specific Aim 2), and altered biomechanics (Specific Aim 3) affect dynamic cervical spine function following fusion. Participants will be C56 (n=22) and C67 (n=22) single-level fusion patients, C456 (n=22) and C567 (n=22) two-level fusion patients, and asymptomatic controls similar in age to the fusion patients (n=22). Patients will be tested prior to surgery, one year post-surgery, and three years post-surgery. At each test, participants will complete clinical questionnaires to assess pain and function, and they will perform full range of motion flexion\extension and axial rotation of the head and cervical spine while biplane radiographs are recorded at 30 images per second. A highly accurate and validated volumetric model-based tracking process and custom data analysis software will be utilized to determine intervertebral kinematics (i.e. translations, rotations, helical axis of motion) and arthrokinematics (i.e. disc deformation and facet joint surface interactions) at each test session.

This prospective study will identify the factors that have the greatest effect on adjacent segment mechanics after cervical fusion. If the hypotheses are confirmed, this will provide support for increased attention to patient-specific factors and surgical technique. Alternatively, if the results indicate that adjacent segment mechanics are influenced primarily by increased stress after arthrodesis, this will provide support for increased attention to the design of motion-sparing devices.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
21 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients must agree to return for all follow-up visits and provide informed consent.
  • Control subjects will be asymptomatic, with no injury or disease that will interfere with spine function, such as previous spine surgery or trauma.

排除标准

  • Participants will have no other injury or disease that will interfere with spine function, such as previous spine surgery or trauma
  • Individuals who have been previously clinically diagnosed with poor bone quality and those who do not intend to stay in the Pittsburgh area for a period of at least 3 years post-surgery will be excluded.
  • Females who are pregnant or plan to be pregnant within 3 years of surgery will be excluded.

结局指标

主要结局

Iatrogenic factors

时间窗: pre-surgery to 3 years post-surgery

adjacent segment disc height and sagittal alignment; graft height, plate placement

Kinematics

时间窗: pre-surgery to 3 years post-surgery

The continuous 3D intervertebral kinematics (translations and rotations).

Arthrokinematics

时间窗: pre-surgery to 3 years post-surgery

Facet joint capsule deformation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

William Anderst

Associate Professor

University of Pittsburgh

研究点 (1)

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